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The Quality Management System (QMS) is vital to any medical device company.
It is not only a regulatory requirement but it sets the framework for how a device is designed, developed, manufactured and distributed.
It also ensures that customer feedback, including complaints are captured and fed back into the system resulting in continual product improvement.
When setting up a QMS it's important to know your business, consider current trends in your industry and develop a process that is efficient and adaptable.
The regulations require that you have a QMS. It's up to you to design a QMS that works for your business.

As the momentum to 'go green' continues to build across the globe, the number of environmental regulations for reducing hazardous substances keeps growing.

At the same time, more and more customers are now setting their own environmental requirements, which is adding even more complexity to the mix.

Ignoring the issue is not an option. To support your environmental compliance objectives, you need a sustainability framework built on a Product Lifecycle Management (PLM) foundation that allows you to phase-out non-sustainable components and materials, and design-in new and innovative 'green' alternatives.

Product reliability isn't optional; it's a significant engineering and business consideration for manufacturers of durable goods because it influences customer satisfaction, brand value, competitiveness of service contracts, and product and service margins.
DfR programs predict product reliability and potential sources of failure, and the potential performance, safety, and economic impacts of failure.

The Internet of things (IoT) is becoming the way of the world and because of it, there are now more components being manufactured and more intricate design chain challenges than ever before.

For small and medium sized enterprises (SMEs), who typically don't know where to start or have the required time and expertise to implement IoT into their processes, surviving this age of digital transformation can seem like a tsunami of data crashing down.

Turning to their Product Lifecycle Management (PLM) system to manage backend activities typically stored in CRM (Customer Relationship Management), issue tracking, and data collection systems -- as well as all of the supply chain activities associated with procurement -- can help SMEs take advantage of the IoT like their larger counterparts.

Product lifecycle management or PLM was once a niche discipline confined to engineers, but has been transformed by digital technology.
Now many sales, operations and customer service executives depend on it.

The Product Lifecycle Management special report reveals how digital is transforming this sector, how the internet of things is changing production, and how PLM is increasingly the lifeblood of many forward-looking businesses.

Frost & Sullivan has found that Omnify delivers unrivaled value to its customers because it offers the ideal PLM solution.
Omnify's customers can expect a superior experience because Empower is the industry's most configurable, easiest to use, most affordable, scalable, customer-centric, and open integration PLM platform available today.

Quality does not own the supplier relationship, but when engaged effectively through leading Supplier Quality Management (SQM) practices it improves the performance of the supply chain. Given the importance of the supply chain in today’s products, this creates benefits not just in supplier quality but across product management, manufacturing, and service. SQM is symbiotic, and improvements to SQM measurably benefit all parties.

Small and Mid-sized Businesses (SMBs) have many compliance requirements levied upon them by regulators, industry, and customers.
SMB manufacturers have the difficult job of interpreting each requirement and deciding when compliance is enough, and when additional investment and effort are warranted.
One such requirement is ISO 9001 – the quality management backbone for many manufacturers – and the new ISO 9001:2015 update.
ISO 9001 is a contractual requirement for certain industries and customers, and SMB suppliers to these industries and customers must be recertified to ISO 9001:2015 by October 2018.

The PLM Grid report is based on more than 150 reviews written by business professionals using Product Lifecycle Management software.

Omnify Software was ranked #1 in Customer Satisfaction in the 2016 G2 Crowd PLM Grid Report. G2 Crowd is the world's leading business software review platform.

The 2016 PLM Grid report is based on more than 150 reviews written by business professionals using Product Lifecycle Management software.
This report will provide you with an independent view of the information you need to know about.

Key areas covered include:

Critical product feature comparisons

Customer satisfaction ratings

Vendor company overviews

Implementation and deployment

Access this online report for free ($599 value) and see why Omnify Empower PLM was named a leader in PLM software and received the highest overall customer satisfaction score out of all reviewed solutions.

Today, doing business globally means compliance with a growing number of "green" regulations that are focused on sustainability.

From the European Union Directives of Restriction of Hazardous Substances (RoHS); Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); and Waste Electrical and Electronic Equipment (WEEE) to the United States Conflict Minerals directive,
manufacturers are hit with a myriad of regulations that can have a major impact on their business processes and success.

What should electronic manufacturers do to be compliant?

Some say it should be dealt with at the manufacturing level, others say the senior management level.
Ultimately, the entire organization should be involved and executive support for implementing formal processes and technology is a must.
However, efficient compliance management should begin at the design level.

This article is based on data from a recent LNS Research report titled, An Enterprise Approach to Quality for SMB Discrete Manufacturers, and focuses on the key reasons SMBs should consider leveraging PLM for quality management.
Taking this approach can help manufacturers produce higher quality products, gain a significant competitive advantage, and meet their overall quality objectives.
By implementing a Product Lifecycle Management (PLM) system, companies both large and small, benefit by simplifying and shortening each phase of the product development process.
Due to their focus on product development and engineering, discrete manufacturers in the small-to-medium sized space (SMB) typically adopt a PLM system to support best in class engineering processes and to address challenges with continual new product introductions, shorter product lifecycles and shrinking profit margins.
Yet, due to budget restraints, quality processes are often managed manually with in-house tools such as Excel spreadsheets.

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions.
Understanding the actual guidelines and best practices for meeting these requirements isn't always clear.
This whitepaper provides answers the top five most common software validation and documentation questions asked by others in FDA regulated industries and demonstrates best practices for meeting the guidelines.

The discrete manufacturing industry, particularly for those organizations competing in the small-to-medium sized business (SMB) space, is well known for its focus on the quick introduction and effective delivery of new products.
While the complexities of these products tend to prompt considerable investments in product lifecycle management (PLM), it is often the case that resources allocated to quality are not considered in the same light.
As a result, robust engineering solutions deliver a capable product development platform, while costly quality issues can surface downstream.

Based on a research survey of SMB quality executives, LNS Research found that quality executives need answers to the following two questions:

1.) What are the best strategies for building quality earlier into the design process?

2.) How do you develop a technology architecture that shares downstream quality process data with the product development team, enabling an environment for continuous improvement?

This Research Spotlight from LNS Research aims to help executives answer these questions and better understand how to use PLM as a platform for delivering quality.

It's no surprise that supply chains are growing in complexity as manufacturers continue to globalize in order to reduce costs and expand their market.
With this shift, manufacturers need to take a new approach to managing their supply chains by finding ways to improve communication with suppliers, obtain early visibility into sourcing information and better mitigate supplier risk.

Many manufacturers are now implementing ways to gather and analyze information earlier in the product's lifecycle, during the planning and design/development phases. This is where Product Lifecycle Management (PLM) comes in.

Due to the fast pace of new technology, emerging market opportunities, and competition from start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

They are discovering that next generation Product Lifecycle Management (PLM) systems may very well be the most valuable investment a medical device manufacturer can make for their medical device development process.

Identifying a clear methodology and an efficient and cost-effective path through the medical device development lifecycle can increase a manufacturer's speed to market while ensuring compliance.

There is a lot of talk about cloud computing today, and its exponentially growing presence among enterprise technology, particularly Product Lifecycle Management (PLM).

While PLM "in the cloud" is available today, its adoption can be slow. Customers are having a difficult time deciphering when, how and even whether to use PLM in a cloud.
With the type of sensitive information that is managed in PLM, there has been some apprehension about moving to the cloud. Adoption is slowly gaining momentum as more customers see the available options and advantages.
The power and potential of cloud computing, properly leveraged and deployed, can have a significant impact on the PLM industry.

PLM customers are giving serious consideration and evaluating their PLM business processes in regard to how to run them seamlessly and securely connect them to cloud-based data sets.
Accessing data, processes and business intelligence in the cloud from a PLM platform could, if done correctly, enable global companies a way to leverage critical information sources, maximize expert resources and manage complex analytics - all from within their PLM system.

It is well known that getting a product to market quickly is critical to a companies' success. There are many steps involved in this process and manufacturers need to continuously find areas to improve upon in order to meet their product goals.

One area that is often overlooked is product test and assembly. Even automated test and assembly processes can take considerable time and effort to prepare, document, and describe all of the required steps and procedures.

Since many manufacturers rely on outsourced partners for test and assembly, inherent problems such as lack of access to product data, time zone/availability issues, and language barriers can often lead to delays in product release schedules.

By implementing a Product Lifecycle Management (PLM) system, companies both large and small, benefit by simplifying and shortening each phase of the product development process.
However, deciding whether or not to adopt PLM software has been a challenge for smaller organizations due to a reputation of PLM being difficult to implement, requiring a great deal of resources to maintain and having excessive initial and long-term costs.
The availability of PLM systems specifically designed for the small to mid-size market has helped to alleviate concerns and opened a door for Small to Mid-size Manufacturing Businesses (SMBs) to be able to take advantage of PLM, and realize the same benefits as their larger counterparts.

For SMBs who are hesitant to adopt PLM, this article offers the top five reasons why they should consider moving forward and investigate solutions (for their market).

*For the purpose of this article, small to medium companies range from start-up to $500 million in revenue.

Quite often a small or medium sized business (SMB) that is looking to gain a competitive advantage will do so by improving their products and streamlining their operations.
Decision makers often look toward technology such as Product Lifecycle Management (PLM) to support these changes.

By implementing a PLM system, companies can simplify and shorten each phase of the product development process.
Selecting new technology is a challenge for any organization but can be especially difficult for the SMB since most software (particularly PLM software) is designed to meet the needs of a large enterprise.

Manufacturers' business needs have changed significantly over the past several years, evolving the roles that technology plays within the manufacturing process.

Two key technologies, Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM), have developed into critical success factors for manufacturers. Each technology brings unique value to the enterprise, and when combined, ERP and PLM provide a wholly collaborative environment that has a major impact on successful product development performance and the ability to maintain a competitive advantage.

According to this report, leading manufacturers are expanding Configuration Management (CM) beyond Bill of Materials (BOMs) to upstream and downstream stages in the product lifecycle and to more product-related information such as product documents, electronic design, and specifications.

This report highlights that best-in-class manufacturers who are using technology such as Product Lifecycle Management (PLM) to centralize their product data and automate their CM processes are twice as likely to meet their product quality targets, 125% more likely to meet their product launch dates, and almost three times more likely to achieve their product lifecycle cost targets.

According to the findings in this report, top performing electronics manufacturers are 84% more likely than average companies to be using PLM solutions.
Electronics manufacturers are challenged with developing more complex products in less time.
In addition, they are doing this with product development teams dispersed around the globe.

Download this report to learn how best-in-class are overcoming these challenges and hitting their product release dates 86% of the time compared to laggards.

Developing, launching, supporting - and ultimately profiting - from new products is challenging.
It requires the integration of business processes and product data across the multiple product development, data management, design, and analysis applications that make up the extended Product Lifecycle Management (PLM) suite.

This report serves as a roadmap for companies seeking to identify Best-in-Class approaches to the integration of the disparate applications within the PLM suite and the extension of those applications into the broader enterprise ecosystem, to achieve higher returns from their product investments.
This report provides a comprehensive guide to how effective organizational process change can translate into improved product design and development efficiency as well as greater market success.